New Drugs — Chain Pharmacy, 6/25/12

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne. The company expects to launch it in the United States in fourth quarter 2012 under an agreement with Canada-based Cipher Pharmaceuticals.

“Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy’s specialized dermatology sales force,” Ranbaxy SVP and regional director for the Americas Venkat Krishnan said.

A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration. Mylan announced the approval of nevirapine tablets in the 200-mg strength. The drug is a generic version of Boehringer Ingelheim’s Viramune. Mylan began shipping the drug immediately after approval. Various versions of the drug had sales of $116.6 million during the 12-month period ended in March, according to IMS Health.

The Food and Drug Administration has approved a new treatment for acne made by a GlaxoSmithKline subsidiary. Stiefel announced the approval of Fabior (tazarotene) foam in the 0.1% strength, calling it the only retinoid in a topical foam for treating acne in patients ages 12 years and older. “Stiefel is dedicated to meeting the needs of patients and dermatologists, and we believe Fabior foam will be an important treatment option for people with moderate to severe acne,” Stiefel VP North America dermatology Jean-Christophe May said.

The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years. Drug maker Novo Nordisk announced the additional approval of Levemir (insulin detemir [rDNA origin]). The insulin already was approved for Type 1 diabetes in older children and adults and Type 2 diabetes in adults, and the drug maker said the new FDA approval made Levemir the only basal insulin analog for use in the 2- to 5-year age group.

Actavis has launched a generic drug for high blood pressure and chest pain, the company said. Actavis announced the launch of nifedipine extended-release tablets in the 90-mg strength, a generic version of Bayer’s Adalat CC. Various versions of the drug had sales of about $23 million in 2011, according to IMS Health.

Pharmacists play role in Wash. pertussis epidemic

Recently, a disease that was long a deadly scourge in the United States has resurfaced: whooping cough.

In April, public health authorities in Washington state declared an epidemic of the childhood disease, also known as pertussis, following a nearly tenfold increase in the number of cases. In May, the state Department of Health found 1,248 cases of the illness, compared with almost 130 at the same time last year. The staggering rise, producing numbers not seen since the 1940s, prompted Gov. Chris Gregoire to announce that emergency funding would be made available to the health department to try and curb the epidemic. The disease is particularly dangerous for infants, and about half of those younger than 1 year old require hospitalization. In light of the situation in Washington, the Centers for Disease Control and Prevention approved the use of federal money designated for other immunizations to buy more than 27,000 doses of pertussis vaccine for adults who are uninsured or underinsured.

There are many reasons for the epidemic, Washington state Department of Health communications director Tim Church told Drug Store News, but in many cases, kids are getting it from adults, who may not be aware that while childhood vaccinations against pertussis may protect against the disease for a while, they can also wear off over time. “That’s why we’re so intent on getting the word out that adults need to get vaccinated,” Church said. “There are far too few adults vaccinated against pertussis.”

Another reason is that the disease is cyclical, Church said; some years have few cases, and some have many. But in this instance, there are even more cases in Washington than there normally would be in a bad year.

Currently, Washington’s state health department offers vaccinations for children for free, and the CDC recommends that children get the Tdap vaccine at age 11. But adults, Church said, are largely on their own. Because Washington has one of the highest rates of parents opting out of getting their kids vaccinated before starting kindergarten, it was suggested in some media reports that it could be one of the reasons for the epidemic, though that remains uncertain.

With the state having limited resources to fight the epidemic, pharmacy retailers have an opportunity to step in where the state doesn’t. In the wake of the state’s declaration of an epidemic, Rite Aid and Walgreens announced the shipment of extra doses of the Tdap vaccine to their stores. Church said he had never seen retail pharmacies so actively promoting Tdap vaccines for adults. “We’ve been pleased with what’s been happening with pharmacies in Washington state,” Church said. “They’re promoting the whooping cough vaccine like never before.”

Pharmacy retailers, Church said, were in a good position to promote the vaccine. “Pharmacists are among the most trusted health providers out there, so we sure would love to see pharmacists ask people coming through if they’re aware there’s a whooping cough outbreak,” Church said. “If people hear those things from pharmacists, it’ll help get more people vaccinated. Retail pharmacies have a lot of resources we don’t have.”

Our surprising readership

Sometimes even I am surprised by who is reading us. Last month, nearly 120,000 unique visitors came to DrugStoreNews.com. One of them was president of the American Academy of Family Physicians Glen Stream.

“In her May 23 article, ‘Physician-authored JAMA article highlights importance of retail clinics, drug store medicine,’ Antoinette Alexander highlights a recently published article that shares a vision for retail health clinics that completely outstrips the capability of these clinics as they are currently configured,” Dr. Stream wrote in his May 31 letter to the editor. To read the entire letter, visit click here.

It does seem odd, though, that the president of a big, national physician’s organization is writing the editor of DSN to debate an article that actually appeared in the Journal of the American Medical Association. But why split hairs? Let’s just chalk it up to DSN’s extensive reach.

Christine Cassel of the American Board of Internal Medicine, the actual author of the JAMA article, half-predicted Stream’s response — and others like him — in her conclusion:

“The question is whether this phenomenon will grow and flourish in the ways described here or whether 20th century attitudes about physician and hospital dominance in health care will prevent market-­based solutions to the healthcare access and cost crisis. This model is a challenge to medical and hospital leadership, as well as to leaders in the retail health clinic industry, as they pursue the potential opportunities and benefits for the American people.”

I may not be smart enough to be the president of the American Academy of Family Physicians. But I’m smart enough to know how to read, and Dr. Cassel, at no point in her article, suggested that retail clinics could or should replace the role of the physician. “The retail clinic potentially could be an important component of coordination of care aimed at reducing disease exacerbations, unnecessary hospitalizations and adverse drug interactions. If this vision were realized, the retail clinic phenomenon could be transformative for a vast number of patients in the United States,” she said.

But all Dr. Stream can see or hear is someone coming to take his job away from him.

Readers respond
I enjoyed reading your column (“Occupy Health Care,” May 21, 2012). … It did make me wonder how ordinary bench pharmacists could be empowered to help Medicare patients [know] about the [free annual wellness visit] physical benefit. It would be a great way to get more people treated, and it would be great for pharmacy.

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